Rift Valley FeverPhase 2RVFNCT03609398
Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
A Phase 2 study testing RVF Vaccine in people with Rift Valley Fever, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rift Valley Fever
- What is being tested?
- RVF Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to Dec 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 to 65 years old at time of consent.
- Have RVF plaque reduction neutralization 80% titers (PRNT80) <1:10 for primary series.
- Have RVF PRNT80 (plaque reduction neutralization 80% titer) <1:40 for booster series.
- If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine administration. (Exception: documented hysterectomy or ≥3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
- Be considered at risk for exposure to RVF virus and who have submitted a Request for IND Vaccines for the RVF vaccine.
- Sign and date the approved informed consent document and HIPAA Authorization.
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- Have in their charts:
- medical history (including concomitant medications) within 60 days of planned first administration of vaccine
- physical examination and laboratory tests within 1 year
- previous chest radiograph results and electrocardiogram
- Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the PI.)
- Be willing to return for all follow-up visits.
- Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study.
- Agree to defer blood donation for 1 year after receipt of the vaccine
Who cannot join
- Have completed previous RVF vaccine study as a nonresponder (PRNT80 <1:40).
- Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
- Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
- Have confirmed HIV infection.
- Have positive pregnancy test or be breastfeeding female.
- Have any known allergies to components of the vaccine:
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- Fetal rhesus monkey lung cells
- Formaldehyde
- Neomycin sulfate
- Streptomycin
- Sodium bisulfite
- Human serum albumin (HAS)
- RVF virus (Entebbe strain)
- Have administration of another vaccine or investigational product within 28 days of RVF vaccination.
- Have any unresolved AE resulting from a previous immunization.
- Have a medical condition that, in the judgment of the PI, would impact subject safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Special Immunization Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, 21702
Anthony P Cardile, DO, MAJ, 301-619-4653, anthony.p.cardile.mil@mail.mil
Jeannine M Haller, RN, CCRP, 301-619-4652, jannine.m.haller.civ@mail.mil
About this study
Official title: A Phase 2 Open Label Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated, Dried, TSI-GSD 200, Lot 7, Run 2, in Adult Subjects at Risk of Exposure to Rift Valley Fever Virus
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
Read the detailed description
This study is being conducted to collect safety and immunogenicity data for the RVF vaccine, TSI-GSD 200, Lot 7, Run 2. Enrollment in this protocol is offered for personnel who enter areas where this virus is used in research or is endemic (an area where this disease process is found to occur frequently). Subjects who respond with a titer of >1:40 may participate for study duration. Rift Valley Fever Vaccine, Inactivated, Dried (TSI GSD 200) will be administered in 1.0-mL doses SQ in the upper outer aspect of the arm.
- Conditions
- Rift Valley Fever
- Being tested
- RVF Vaccine
- Medical subject headings
- Rift Valley Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVF VaccineBiological
1.0 mL dose given SQ in upper arm
| Study group | Role | What they receive |
|---|---|---|
| RVF Vaccine | Experimental | 1.0 mL dose given SQ in upper arm Receives: Biological: RVF Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine
Safety assess of local and systemic adverse events and their relationship to the study vaccine. AEs will be recorded for 28 days after each dose of the vaccine for the assessment population (all subjects who receive at least one vaccination under this protocol. Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Measured: 0-28 days after each dose
Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects
Percentage of per-protocol subjects (subjects who adhered to the protocol schedule for both vaccination and blood collects) who developed titers ≥1:40 as determined by PRNT80 (plaque reduction neutralization 80% titer) after vaccination at each scheduled time point for which blood samples are drawn and over the entire study period.
Measured: 21-35 days after each vaccination and month 12
Secondary outcomes (2)
Frequency and Severity of Adverse Events
Frequency and severity of adverse events for the assessment population (all subjects who receive at least one vaccination under this protocol). Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Measured: 0-28 days after each dose
Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects
Geometric mean PRNT80 (plaque reduction neutralization 80% titer) of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Measured: 21-35 days after each vaccination and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start4 Oct 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rift Valley FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- vaccine to be administered in 1.0mL doses SQ in the upper outer aspect of the arm
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609398
- Sponsor's protocol ID
- S-16-12
- Acronym
- RVF
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2018
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No